Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
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File ref: TT50-8560a |
Trade Name | Dose Form | Strength | Identifier |
Arrow - Amlo 10 | Tablet | 10 mg | |
Sponsor | Application date | Registration situation | Classification |
Actavis New Zealand Limited P O Box 128 244 Remuera Auckland 1541 | 26/4/2010 | Approval lapsed Approval date: 23/9/2010 Notification date: 21/9/2020 | Prescription |
Reference product: Norvasc Tablet 10 mg |
Composition
Component | Ingredient | Manufacturer |
tablet | Active | |
Amlodipine besilate 13.88mg equivalent to 10 mg Amlodipine | Dr Reddy's Laboratories Limited Unit III, Plot No 116, IDA Bollaram Jinnaram Mandal Sangareddy District Telangana 502 325 INDIA | |
Glochem Industries Pvt. Limited Survey Nos. 36, 37 & 46, Plot No. 77 Jawaharlal Nehru Pharmacity Thanam Village, Parawada Mandal, Visakapatnam Andhra Pradesh 502 325 INDIA | ||
Excipient | ||
Calcium hydrogen phosphate dihydrate | ||
Colloidal silicon dioxide | ||
Magnesium stearate | ||
Microcrystalline cellulose | ||
Sodium starch glycolate |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Ipca Laboratories Limited Plot No 255/1 Athal Silvassa Dadra and Nagar Haveli (U T) 396 230 INDIA |
Manufacture of Final Dose Form | Ipca Laboratories Limited Plot No 255/1 Athal Silvassa Dadra and Nagar Haveli (U T) 396 230 INDIA |
Packing | Ipca Laboratories Limited Plot No 255/1 Athal Silvassa Dadra and Nagar Haveli (U T) 396 230 INDIA |
NZ Site of Product Release | Actavis New Zealand Limited 33A Normanby Road Mount Eden AUCKLAND |
Packaging
Package | Contents | Shelf Life |
Blister pack, PVC/PVDC | 28 tablets | 24 months from date of manufacture stored at or below 25°C |
Blister pack, PVC/PVDC | 56 tablets | 24 months from date of manufacture stored at or below 25°C |
Blister pack, PVC/PVDC | 84 tablets | 24 months from date of manufacture stored at or below 25°C |
Bottle, plastic, HDPE | 100 tablets | 24 months from date of manufacture stored at or below 25°C |
Bottle, plastic, HDPE | 250 tablets | 24 months from date of manufacture stored at or below 25°C |
Bottle, plastic, HDPE | 500 tablets | 24 months from date of manufacture stored at or below 25°C |
Indications
Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor.
Amlodipine is indicated for the first line treatment of myocardial ischaemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
20/10/2014 | Self-Assessable Change Notification | Finished product specifications/test methods - Grade 1 (Self assessable) | Notified | 23/10/2014 | |
26/4/2010 | New Intermediate-risk Medicine Application | Additional name - Grade 1 | Granted 23/9/2010 | 11/5/2010 |